Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 9-10, and 33-34 are pending in the application and are the subject of this office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 March 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9-10, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Swagemakers et al (US 2011/0059089 A1; previously cited).
Regarding claims 1, 9 and 34, Swagemakers teaches a method for diagnosing or predicting the risk of a cardiovascular event in a human subject (Par. 72: the invention provides the use of a biomarker as defined herein for diagnosing or predicting the risk of a cardiovascular event in a subject; claim 10; Par. 16: the cardiovascular event may be selected from: vascular death or sudden death, fatal or non-fatal stroke, fatal or non-fatal myocardial infarction, fatal or non-fatal rupture of abdominal aortic aneurysm, rupture of abdominal aortic aneurysm confirmed by laparotomy, vascular intervention, coronary artery disease, TIA, peripheral arterial disease, acute coronary syndrome, heart failure, or restenosis; Par. 125: human subject);
Swagemakers further teaches the method comprising measuring a concentration of the NPC2 protein and IGFBP7 protein in a sample from the subject, wherein the sample may be selected from the group consisting of serum, plasma, and blood (Par. 15, 22, 24, 135; Par. 37: in a preferred embodiment, said biomarker comprises at least one protein selected from a group comprising both NPC2 and IGFBP7. In a preferred embodiment, the biomarker comprises 85 of the proteins referred to in the group. In one embodiment the biomarker comprises all of the proteins in the group).
Though Swagemakers does not explicitly state that the sample is obtained from a subject having an arteriosclerosis-related disease selected from MI, PAD, aortic aneurysm caused by atherosclerosis, aortic dissection, atherothrombotic cerebral infarction, TIA, renal artery stenosis, internal carotid artery stenosis, and angina pectoris, Swagemakers teaches a method of diagnosing or predicting a cardiovascular event which may be MI, PAD, aortic aneurysm caused by atherosclerosis, stroke (e.g. atherothrombotic cerebral infarction, TIA) (Par. 16), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included samples from subjects who have (claim 1) or are suspected of having (claim 34) these specific arteriosclerosis-related diseases for the purpose of carrying out diagnosis of these diseases for the proper assessment and treatment of the subject (i.e. diagnosis of the condition implies that the subject from which the sample is taken has the condition). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Swagemakers is specifically directed to prediction and diagnosis of arteriosclerosis-related cardiovascular events.
Swagemakers teaches measuring a concentration of NPC2 and IGFBP7 protein in a sample from a human subject, as discussed above, but does not explicitly teach that the NPC2 protein has the amino acid sequence of SEQ ID NO: 1 or that the IGFBP7 protein has the amino acid sequence of SEQ ID NO: 2.
However, the instant specification discloses that these are the amino acid sequences of human NPC2 and human IGFBP7 (see specification Par. 20-22), while Swagemakers teaches detection of human NPC2 and human IGFBP7 in a sample from a human. As such, one of ordinary skill in the art would reasonably assume that the human NPC2 protein and human IGFBP7 protein detected in the method disclosed by Swagemakers has the amino acid sequence of SEQ ID NO: 1 and SEQ ID NO: 2, respectively.
Regarding claim 10, Swagemakers further teaches the method wherein the measurement method is immunoassay (Par. 65).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Swagemakers et al (US 2011/0059089 A1; previously cited) as applied to claim 1 above, and further in view of Boulanger et al (Long-Term Risk of Myocardial Infarction Compared to Recurrent Stroke After Transient Ischemic Attack and Ischemic Stroke: Systematic Review and Meta-Analysis. J Am Heart Assoc. 2018 Jan 18;7(2):e007267.) and Plate et al (Recurrent Aneurysms and Late Vascular Complications Following Repair of Abdominal Aortic Aneurysms. Arch Surg. 1985;120(5):590–594.).
Regarding claim 33, Swagemakers teaches the method of claim 1, as described above. Swagemakers does not specifically teach the method wherein the subject has a recurrence of the arteriosclerosis-related disease.
Regarding claim 33, Boulanger discusses risks of recurrent cardiovascular events (Abstract). Specifically, Boulanger teaches that patients who have experienced TIA are at risk of recurrent stroke/TIA. Boulanger also teaches that patients with PAD are at increased risk of myocardial infarction (Abstract).
Regarding claim 33, Plate teaches that recurrent aneurysms are a significant cause of later morbidity and mortality after repair of abdominal aortic aneurysm in a patient (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swagemakers to specifically include subjects with recurrence of arteriosclerosis-related disease. One would be motivated to specifically include these subjects in Swagemakers method of predicting and diagnosing cardiovascular events and arteriosclerosis related diseases because Boulanger and Plate both teach that patients with a history of certain arteriosclerosis related diseases are at increased risk of recurrence of arteriosclerosis-related diseases or of mortality by arteriosclerosis-related diseases. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Swagemakers is directed to methods of diagnosing and predicting cardiovascular events.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 9-10, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9-11 of copending Application No. 17/043,195 in view of Swagemakers et al (US 2011/0059089 A1; previously cited).
Regarding instant claims 1 and 34, all limitations of instant claims 1 and 34 are taught by reference claims 1, 5 and 11, with the exception that reference claim 1 does not teach detection of IGFBP7 and teaches that the body fluid sample is obtained from a subject suspected of having aortic aneurysm rather than a subject having aortic aneurysm as in instant claim 1.
Reference claims 5 and 11 and Swagemakers all teach that both NPC2 and IGFBP7 can be detected in a sample from a subject as biomarkers of arteriosclerosis related disease and aortic aneurysm (Swagemakers, Par. 15-16, 37).
As such, it would have been obvious to one of ordinary skill in the art to modify the method of reference claim 1 to further include detection of both NPC2 and IGFBP7. One of ordinary skill in the art would be motivated to make this modification because reference claim 1 is directed to a method of detecting biomarkers in a sample from a subject suspected of having aortic aneurysm and both Swagemakers and reference claims 5 and 11 teach that NPC2 and IGFBP7 are both biomarkers associated with aortic aneurysm, such that one of ordinary skill in the art who is detecting biomarkers of and screening for aortic aneurysm would be motivated to detect multiple biomarkers associated with the condition for the purpose of gathering more data associated with aortic aneurysm presence and risk. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because reference claims 1, 5, and 11 and Swagemakers are all detected to measurement of aortic aneurysm biomarkers in a body fluid sample obtained from a subject.
Regarding instant claim 1, although the reference claims and Swagemakers do not explicitly state that the sample is obtained from a subject having an arteriosclerosis-related disease such as aortic aneurysm, Swagemakers teaches a method of diagnosing or predicting a cardiovascular event which may be aortic aneurysm (Par. 16), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included samples from subjects who have aortic aneurysm for the purpose of carrying out diagnosis of these diseases for the proper assessment and treatment of the subject (i.e. diagnosis of the condition implies that the subject from which the sample is taken has the condition). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Swagemakers are specifically directed to measurement of aortic aneurysm biomarkers in a body fluid sample obtained from a subject.
All additional limitations of instant claims 9-10 are taught by reference claims 9-10,
This is a provisional nonstatutory double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claims 1, 5, and 11 of copending Application No. 17/043,195 in view of Swagemakers et al (US 2011/0059089 A1; previously cited), as applied to instant claim 1 above, and further in view of Plate et al (Recurrent Aneurysms and Late Vascular Complications Following Repair of Abdominal Aortic Aneurysms. Arch Surg. 1985;120(5):590–594.).
Regarding instant claim 33, reference claim 1 in view of Swagemakers meets the limitations of instant claim 1 as described above. The reference claims do not specifically teach the method wherein the subject has a recurrence of arteriosclerosis-related disease.
Regarding claim 33, Plate teaches that recurrent aneurysms are a significant cause of later morbidity and mortality after repair of abdominal aortic aneurysm in a patient (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the reference claims to specifically include subjects with recurrence of arteriosclerosis-related disease such as aortic aneurysm. One would be motivated to specifically include these subjects in the reference claims’ method of detecting aortic aneurysm because Plate teaches that recurrent aneurysm is a significant cause of morbidity and mortality in patients following abdominal aortic aneurysm repair. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims are directed to methods of detecting aortic aneurysm.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed 27 March 2026 have been fully considered.
Regarding the 103 rejection, Applicant argues that the rejection does not properly teach the amended claim which explicitly requires measurement of both NPC2 and IGFBP7 in the sample. This argument is not persuasive. Swagemakers, at Par. 37 (cited in the reference above) teaches: (in a preferred embodiment, said biomarker comprises at least one protein selected from a group comprising both NPC2 and IGFBP7. In a preferred embodiment, the biomarker comprises 85 of the proteins referred to in the group. In one embodiment the biomarker comprises all of the proteins in the group). As such, Swagemakers explicitly teaches an embodiment of the disclosed method which requires measurement of both IGFBP7 and NPC2 in a sample.
Applicant further argues that the instant specification explains that NPC2 and IGFBP7 are markers that, when used in combination, make it possible to obtain more detailed information regarding the stage and progression of arteriosclerosis, and yield a superior detection effect. Applicant argues that the success of the claimed combination depends on the newly demonstrated insight that the two markers reflect different aspects of the disease, and that this result would not have been predictable from Swagemakers which does not teach that NPC2 is informative for plaque presence and baPWV while IGFBP7 is informative for maxIMT. These arguments are not persuasive because they do not create any patentable distinction between the prior art and what is explicitly claimed. That is, the prior art only needs to teach the explicitly recited steps and elements of the claimed method in order to read on the instant claim, and Swagemakers teaches all recited elements of the claim, as described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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